Novartis and Medicines for Malaria Venture Seeks to Advance Ganaplacide/Lumefantrine-SDF Combination Therapy in P-III Study for Malaria
- Novartis and MMV plans to initiate the P-III trial in 2023 to evaluate the efficacy of ganaplacide/lumefantrine-SDF vs artemether-lumefantrine in patients with acute uncomplicated malaria due to Plasmodium falciparum at clinical sites in Burkina Faso, Mali, Gabon, Niger & other sites in sub-Saharan Africa. The trial is being conducted in collaboration with the WANECAM 2 consortium
- The P-II study met the 1EPs i.e., patients treated with ganaplacide/lumefantrine-SDF (qd) during 3 days responded to treatment & was similar to patients who received artemether-lumefantrine control therapy (BID) during 3 days
- The P-II & III studies received funding from EDCTP. The combination therapy received FTD & ODD from the US FDA for acute, uncomplicated malaria in Aug 2022
Ref: Novartis | Image: Novartis
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